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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046082
Receipt No. R000052604
Scientific Title Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/16

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Basic information
Public title Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Acronym Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Scientific Title Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Scientific Title:Acronym Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the relationship between intestinal permeability and lymphocytes.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in interepithelial electrical resistance
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patient's written consent to participate in the research must be obtained.
Eligible patients must be diagnosed with ulcerative colitis or Crohn's disease.
The healthy control is a faculty member of Shimane University School of Medicine and has not been diagnosed with either ulcerative colitis or Crohn's disease.
Key exclusion criteria Healthy controls are those with abnormal findings on gastrointestinal endoscopy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Kishimoto
Organization Shimane University, Faculty of Medicine
Division name Internal Medicine II
Zip code 693-8501
Address 89-1, Enya-tyo, Izumo city, Shimane prefecture
TEL 0853-20-2190
Email kk0901@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Kishimoto
Organization Shimane University, Faculty of Medicine
Division name Internal Medicine II
Zip code 693-8501
Address 89-1, Enya-tyo, Izumo city, Shimane prefecture
TEL 0853-20-2190
Homepage URL
Email kk0901@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shimane University, Faculty of Medicine
Address 89-1, Enya-tyo, Izumo city, Shimane prefecture
Tel 0853202111
Email kk0901@med.shimane-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison of intestinal permeability of each lymphocyte

Management information
Registered date
2021 Year 11 Month 16 Day
Last modified on
2021 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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